Kornimate/medical-research-clean huggingface dataset:
study of aspirin in patients with vestibular schwannoma

Conditions: Vestibular Schwannoma; Acoustic Neuroma; Neurofibromatosis 2

Summary: this is a phase ii prospective, randomized, double-blind, longitudinal study evaluating whether the administration of aspirin can delay or slow tumor growth and maintain or improve hearing in vs patients.

this is a phase ii prospective, randomized, double-blind, longitudinal study evaluating whether the administration of aspirin can delay or slow tumor growth and maintain or improve hearing in vs patients. in the randomized treatment phase, patients aged 12 years or older with vss will be identified and recruited into one of two randomized groups who receive either 1) 325 mg aspirin twice daily (81 mg aspirin twice daily for pediatric patients \<50 kg); or 2) a placebo. patients will stay on aspirin/placebo as long as there is no more than 20% increase in vs volume. at tumor progression, patients will enter the open label follow up phase. patients who progress on placebo will be given the option to receive unblinded aspirin and will be followed until further progression, receiving a definitive treatment (e.g, surgery or radiation), or 42 months post-baseline, whichever occurs first. patients who progress on aspirin (either blinded or unblinded) will be taken off study drug and followed until they receive a definitive treatment (e.g., surgery or radiation) or reach 42 months post-baseline, whichever comes first.

Eligibility criteria:
inclusion criteria: * radiographic diagnosis of vestibular schwannoma (nf2-associated or sporadic). * age≥12 years. * ability to provide informed consent.pediatric patients must provide assent in addition to their parents'/guardians' consent. adult patients who cannot consent for themselves will not be eligible to participate in this study. * ability to swallow tablets. exclusion criteria: * inability to perform volumetric measurements of vestibular schwannoma(s). * inability to tolerate mri with contrast. * daily use of aspirin within the last two months. occasional use of aspirin for pain relief is not exclusionary. * known allergy to aspirin. * impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of aspirin. * pregnant or lactating women. * patients with serious medical illnesses (e.g. severe asthma) that in the option of the investigator could prevent participation in the trial. * active bleeding diathesis. * hydrocephalus from brainstem compression. * febrile illness or flu-like illness in children and adolescents less than 18 years of age.
factors related to a persistent inadequate bowel preparation for colonoscopy

Conditions: Colonic Disease

Summary: adequate bowel preparation for colonoscopy has an extremely relevant impact on diagnostic yield and procedural success. the guidelines recommend an adequate colon cleansing rate of at least 90% of procedures. it has been shown that patients with inadequate colon cleansing history have a high probability of not reaching an adequate bowel preparation again. surprisingly, no evidence-based recommendations are available regarding bowel preparation in the patient with inadequate colon cleansing history. therefore, identifying the factors associated with repeated inadequacy of bowel cleansing is crucial in order to define the best preparation strategy in this subset of patients. the implications for patients and for healthcare system are many: improving the quality of bowel preparation would reduce the need to repeat colonoscopy and the risk of conducting unreliable examinations. furthermore, it would reduce the costs for the healthcare system by avoiding to overload endoscopic units. inclusion criteria: outpatient and hospitalized patients, adults, candidates for colonoscopy for any pathology, as part of the normal care process, with the need to repeat bowel preparation due to inadequate cleansing. exclusion criteria: * emergency regime * inability to obtain consent * refusal of the patient primary end-point: identification of factors independently associated with repeated inadequate colon cleansing after inadequate bowel preparation at previous colonoscopy, and consequent development (and validation) of a predictive model. the colon cleansing will be evaluated according to the boston bowel preparation scale (bbps), which assigns a score from 0 (presence of solid stools) to 3 (excellent visualization of the colonic mucosa) for each of the three main segments of the colon, i.e. right colon, transverse colon and left-rectum colon. colon cleansing will be judged inadequate in case of a total score \<6 or a score \<2 even in only one of the colic segments. secondary end-point: • assess the prevalence of repeated inadequate bowel cleansing in the patient with previous inadequate cleansing


Eligibility criteria:
inclusion criteria: * outpatients or hospitalized patients * adults * candidates for colonoscopy for any pathology, in the normal pathway of care, with the need to repeat the bowel preparation due to inadequate colon cleansing. exclusion criteria: * emergency regimen * inability to obtain consent * patient refusal
a study of sgn-40 in combination with rituximab in patients with cd20-positive, follicular and marginal zone b-cell non-hodgkin's lymphoma

Conditions: Non-Hodgkin's Lymphoma

Summary: this is an open-label, multicenter phase ib study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of sgn-40 when combined with rituximab in patients with relapsed cd20-positive, follicular or marginal zone nhl who have received at least one prior rituximab-containing regimen.


Eligibility criteria:
inclusion criteria: * documented history of histologically confirmed cd20-positive, follicular nhl or marginal zone nhl * at least one previous treatment with rituxan monotherapy or a rituximab-containing regimen * measurable disease * either fresh or archived tumor specimen must be available for central confirmation of diagnosis and correlative studies * life expectancy of \> 3 months * for patients of reproductive potential, use of a reliable means of contraception exclusion criteria: * chemotherapy or radiotherapy within 28 days of day 1 * prior treatment with a monoclonal antibody directed against cd40 * radioimmunotherapy or immunotherapy with a monoclonal antibody other than rituximab within 3 months of day 1 * prior treatment with an investigational drug within 28 days of day 1 * prior allogeneic bone marrow transplant * prior autologous hematopoietic stem cell transplant within 12 weeks of day 1 * concurrent systemic corticosteroid therapy * prior anaphylactoid or other serious reaction to rituximab that resulted in hospitalization or discontinuation of therapy, or both * evidence of clinically detectable ascites on day 1 * other invasive malignancies within 3 years prior to day 1 except for adequately treated basal cell or squamous cell skin cancer, in situ carcinoma of the cervix, in situ breast cancer, in situ prostate cancer, or other cancer of which the patient has been disease-free for at least 3 years * history or evidence on physical examination of cns disease * active infection requiring parenteral antibiotics within 14 days of day 1 * major surgical procedure (excluding lymph node biopsy) or significant traumatic injury within 28 days prior to day 1 * pregnancy (positive pregnancy test) or lactation * serious, nonhealing wound, ulcer, or bone fracture * clinically significant cardiovascular disease, congestive heart failure, serious cardiac arrhythmia requiring medication within 1 year prior to day 1. grade ii or greater peripheral vascular disease at study entry. * known human immunodeficiency virus (hiv) infection * known serious medical conditions, including cirrhosis, hepatitis c infection, and chronic obstructive or chronic restrictive pulmonary disease

Keywords: nhl rituxan anti-cd40
maternal opioid treatment: human experimental research - data yield appropriate decisions

Conditions: Opioid-use Disorder; Opioid Withdrawal; Neonatal Abstinence Syndrome; Neonatal Opioid Withdrawal Syndrome

Summary: this study will compare medically-supervised withdrawal (msw, 'detoxification') to opioid agonist treatment (oat, 'maintenance') with buprenorphine for pregnant women with opioid use disorder in terms of maternal, fetal, and neonatal outcomes. outcomes will be assessed during pregnancy, at birth and for 12 months postpartum. this study has the potential to impact health service policy and practices in terms of the treatment options of pregnant women with opioid use disorder.

some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. they will be included after the trial is complete.

Eligibility criteria:
inclusion criteria: * be ages 18 to 41, inclusive * have a single fetus pregnancy between 6-30 weeks estimated gestational age * willing to participate in the study exclusion criteria: * non-english speaking
step up versus step down in controlled ovarian stimulation

Conditions: No Explained Sterility

Summary: the aim of the study is to evaluate if the step up protocol is equal or superior regarding efficacy and security than the step down protocol. in couple submitted two intrauterine insemination.


Eligibility criteria:
inclusion criteria: * women with unexplained sterility with needs of intrauterine insemination. exclusion criteria: * contraindications to intrauterine insemination.

Keywords: sterility fsh-r intrauterine insemination unexplained sterility
vaccine therapy in treating patients with resected or locally advanced unresectable pancreatic cancer

Conditions: Pancreatic Cancer

Summary: rationale: vaccines may help the body build an effective immune response to kill tumor cells. purpose: this phase i trial is studying the side effects and best dose of vaccine therapy in treating patients with resected or locally advanced unresectable pancreatic cancer.

objectives: i. determine the safety and toxicity of vaccination with muc-1 antigen and immunologic adjuvant sb as-2 in patients with resected or locally advanced unresectable pancreatic cancer. ii. determine the maximum tolerated dose and/or recommended phase ii dose of muc-1 antigen in this patient population. iii. determine the qualitative and quantitative tumor response to this treatment in these patients. iv. determine the disease-free survival in resected patients, progression-free survival in locally advanced unresectable patients, and overall survival in all patients receiving this treatment. outline: this is a dose escalation study of muc-1 antigen. patients receive vaccination with muc-1 antigen and immunologic adjuvant sb as-2 intramuscularly on day 1. treatment repeats every 3 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity. beginning 1 year after the last vaccination, patients without recurrent disease may receive booster vaccines annually. cohorts of 4 to 8 patients receive escalating doses of muc-1 antigen until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 4 or 2 of 8 patients experience dose-limiting toxicity. patients are followed at 2 weeks. projected accrual: a total of 15-20 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically confirmed resected or locally advanced unresectable pancreatic cancer no metastases patient characteristics: age: over 18 performance status: ecog 0-2 life expectancy: at least 4 months hematopoietic: wbc greater than 3,500/mm3 platelet count greater than 100,000/mm3 hepatic: bilirubin no greater than 2.0 mg/dl renal: creatinine no greater than 1.5 mg/dl other: not pregnant or nursing negative pregnancy test fertile patients must use effective double barrier contraception 1 week before, during, and for at least 2 weeks after study prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy endocrine therapy: no concurrent glucocorticosteroids radiotherapy: no prior radiotherapy surgery: at least 3 weeks since prior resection of pancreatic cancer other: no concurrent non-steroidal anti-inflammatory drugs (nsaids)

Keywords: stage i pancreatic cancer stage ii pancreatic cancer stage iii pancreatic cancer stage iv pancreatic cancer
study on akin osteotomy: fixation versus non-fixation (fixakin)

Conditions: Akin Osteotomy; Hallux Valgus

Summary: we hypothesize that the akin screw fixation osteotomy technique provides better postoperative mobility of the metatarsophalangeal hallux joint compared to the non-fixation technique.

compare the screw fixation technique of akin's osteotomy, compared to the technique without fixation, on the postoperative mobility of the metatarsophalangeal joint of the hallux at one year postoperatively in patients ( patients operated on for an isolated hallux valgus, that is to say without any associated lateral movement, by percutaneous technique (mica or perc).

Eligibility criteria:
inclusion criteria: * patient over 18 years-old * patient undergoing percutaneous surgery for hallux valgus with first hybrid and / or percutaneous ray procedure without rotation disorder, * first line surgery, * absence of metatarsophalangeal osteoarthritis, * persistence of mobility of the hallux metatarsophalangeal gland, * subject benefiting from a social protection insurance * patient having signed the free and informed consent / patient having given his express consent / patient having been informed and not opposing this research. exclusion criteria: * rotation disorder, * rheumatoid foot, * hallux rigidus. * patient participating in another clinical study * minors: * adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision; * pregnant, breastfeeding or parturient woman; * hospitalized without consent.
culturally-adapted mobile health intervention for hypertension care

Conditions: Hypertension

Summary: a single-arm study to assess the ability of the ahomka platform for hypertension management to affect blood pressure change among urban and rural patients in ghana.


Eligibility criteria:
inclusion criteria: * diagnosis of hypertension exclusion criteria: * comorbidities

Keywords: hypertension, mobile health
sensor-based balance training with exergaming biofeedback

Conditions: Stroke, Ischemic

Summary: the purpose of this study is to evaluate the effects of a sensor-based balance training with exergaming feedback on balance skills in chronic stroke patients.

stroke is a leading cause of disability globally, with many survivors experiencing persistent balance impairments that affect the quality of their life. in this context, the use of balance-focused rehabilitation might represent a promising strategy over traditional methods. the integration of biofeedback and advanced technology in rehabilitation, such as audiovisual feedback, can enhance cortical activation, sensory integration, and patient engagement. exergaming, a specific form of biofeedback, exhibits potential in improving functional recovery and motivation in stroke rehabilitation. in fact, visual feedback has shown effectiveness in chronic stroke patients. given the rising incidence of stroke and the associated challenges, it is crucial to explore new intervention strategies that leverage technological advancements for better balance recovery. previous studies have shown promising results in subacute stroke patients using an integrated biofeedback system that combine inertial measurement units (imus) and a sensorized force platform. the current study aims to evaluate the effects of sensor-based training with exergaming feedback on balance functions in individuals with chronic stroke.

Eligibility criteria:
inclusion criteria: 1. single event of cortical/subcortical ischemic stroke. 2. onset \> 180 days. 3. lesion confirmed thought magnetic resonance (mr) or computer tomography (ct). 4. able to stand upright with supervision or minimal assistance. exclusion criteria: 1. severe general impairment or concomitant diseases (i.e., parkinson disease). 2. orthopaedic contraindications. 3. cognitive impairment (mini mental state examination \< 23). 4. diagnosis of unilateral spatial neglect.

Keywords: chronic ischemic stroke
a pharmacokinetic study of ro5185426 in combination with a drug cocktail in patients with metastatic melanoma

Conditions: Malignant Melanoma

Summary: this open-label single-arm study will evaluate the effect of ro5185426 \[rg7204; plexxikon: plx4032\] on the pharmacokinetics of five cyp450 substrates (caffeine, warfarin + vitamin k, omeprazole, dextromethorphan, midazolam) administered as a drug cocktail to patients with metastatic melanoma. the study will also evaluate efficacy and safety of ro5185426. on day 1, patients will receive the drug cocktail. on days 6 to 19, patients will receive ro5185426 twice daily. on day 20, patients will receive ro5185426 and the drug cocktail and on days 21 to 25, patients will receive ro5185426. assessments will be made at regular intervals during the dosing periods and at follow-up. patients may continue on study treatment (ro5185426) until the development of progressive disease or unacceptable toxicity. target sample size \<50.


Eligibility criteria:
inclusion criteria: * adult patient \>/= 18 years of age * malignant melanoma (stage iv, ajcc) * patients who are treatment-naive or have received prior systemic treatments for metastatic melanoma. time elapsed between previous treatment for metastatic disease and first administration of study drug must be at least 28 days * positive tested for braf mutation * patients must not be poor metabolizers of cyp450 enzymes 2c9, 2c19, or 2d6 as determined by genotyping * measurable disease by recist criteria * negative pregnancy test; for fertile men and women, effective contraception during treatment and for 6 months after completion exclusion criteria: * active cns lesions on ct/mri within 28 days prior to enrollment * history of known spinal cord compression, or carcinomatous meningitis * severe cardiovascular disease within 6 months prior to study
photobiomodulation in post menopause genitourinary syndrome

Conditions: Postmenopausal Symptoms

Summary: the goal of this project is to evaluate the clinical response of patients with symptoms of genitourinary menopause syndrome after the application of photobiomodulation in the vagina and its introit. method: in this randomized, double-blind, placebo-controlled study protocol, women over 50 years of age who are in the postmenopausal period (amenorrhea for at least 12 months, with no pathology involved) with one or more symptoms of pgs will be selected. participants included in the study will be randomly divided into two groups: group a, which will receive photobiomodulation with a vaginal diode laser and its introit and group b (placebo) with the laser device turned off. both treatments will be maintained for 4 consecutive weeks.the treatment group (n=30) will receive four consecutive applications, using laser diode dmc (808 nm), 4j per point, 100mw of power, 510mw/cm², beam area of 0.2cm², 8 sites in the external vagina, for the 40s in each site, once per week for 4 weeks. the placebo group (n=30) will be handled as treated, but with the laser turned off. quality of life will be analyzed using the female sexual functioning index (fsfi-6), the urinary incontinence questionnaire (iciq-sf), the intensity of menopausal symptoms will be evaluated using a visual analogue scale (vas), the vulvo vaginal atrophy will be measured by the vaginal health index (vhi) and compared between groups. also, the vaginal temperature will be measured using a thermal camera, as well as the pressure of the pelvic floor force (vaginal dynamometer) and a 1-hour pad test will be performed to quantify the urinary loss. the data will be tested for normality using the shapiro wilks test and, if they present a parametric distribution, they will be represented by means of their respective means and standard deviations.


Eligibility criteria:
inclusion criteria: * women over 50 years of age who are in the postmenopausal period (amenorrhea for at least 12 months, with no pathology involved); * with one or more symptoms of ugs (dyspareunia, dryness, irritation and vaginal burning and/or discomfort, vaginal atrophy, vaginal and vulvar dryness, dysuria, frequency, recurrent urinary infections); * with complaints of stress and/or urge urinary incontinence; * who have cervical cytopathology (pap smear) within the normal range performed in the last year and are not in use of hormonal medication to treat menopausal symptoms in the last 6 months. exclusion criteria: * participants with explicit refusal of the patient to participate in the researc; * history of bilateral oophorectomy and diseases such as: recent ami (acute myocardial infarction), neoplasms, history of thrombosis, liver failure, uncontrolled genital bleeding, genital condylomatosis, active genital herpes, lower genital tract surgeries that make treatment impossible.
a study to evaluate the safety and efficacy of hetrombopag olamine in severe aplastic anemia （saa） patient

Conditions: Severe Aplastic Anemia

Summary: this is a multicentre, open-label, single-arm, phase ii study to evaluate the safety and efficacy of hetrombopag olamine in patients with severe aplastic anemia. 55 adult patients with saa will be enrolled in the study. treatment with hetrombopag will be started at 7.5 mg/day and uptitrated according to the platelet count. the primary objective of the study is to assess the safety and efficacy of hetrombopag in patients with saa.


Eligibility criteria:
inclusion criteria: 1. previous diagnosis of refractory severe aplastic anemia, not meeting partial response criteria after at least one treatment course of immunosuppressive therapy, not suitable or unwilling to do hematopoietic stem cell transplantation. 2. platelet count ≤ 30×109/l. 3. signed informed consent. exclusion criteria: 1. bleeding and/or infection not adequately responding to appropriate therapy. 2. patients with a pnh clone size in neutrophils of ≥50%. 3. treatment with immunosuppressive therapy within 6 months prior to study entry. 4. any laboratory or clinical evidence for hiv infection. any clinical history for hepatitis c infection; chronic hepatitis b infection; or any evidence for active hepatitis at the time of subjects screening. 5. alt\> 2.5 x upper limit of normal (uln), ast\> 2.5 x upper limit of normal (uln) dbli\> 1.5 x upper limit of normal (uln), scr\> upper limit of normal (uln). 6. subjects diagnosed with cirrhosis or portal hypertension. 7. subjects diagnosed with tumor. 8. patients with any prior history of congestive heart failure, arrhythmia, and peripheral arteriovenous thrombosis within 1 year. with a history of myocardial infarction or cerebral infarction within 3 months. 9. ecog performance status of 3 or greater. 10. female subjects who are nursing or pregnant within 6 months. 11. subjects cannot take effective contraception. 12. subjects have participated in other clinical trial within the 3 months prior to study entry.

Keywords: saa